Commissioning and Qualification Lead

About PSC Biotech

Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Take your Career to a new Level
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition
Employees are the heartbeat of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

• Be part of a multi-discipline team (in a seconded client role) responsible for Commissioning & Qualification (C&Q) activities on a large Drug Product facility, directing the activities of our C&Q partner on site.
  
• The successful candidate will be able to demonstrate a proven track record to take systems from the Design Phase through Construction Handover stage and carry them through the Commissioning and Validation cycle to allow handover to Manufacturing.
  
• The candidate will be a convincing communicator with strong interpersonal skills to lead a team of Commissioning and Qualification engineers.
  
• This candidate will be required to work closely with a cross-functional team and coordinate activities between Construction, Process, Technical Operations, IPT and QA.
  

This candidate will be required to have an understanding of digital execution methods (ie. KNEAT) for digital execution of C&Q lifecycle deliverables.

Responsibilities:

• Report to the Global C&Q Lead.
  
• Lead and coordinate a commissioning and qualification program for Drug Product formulation and filling, clean and black utilities, support services, and laboratory equipment.
  
• Lead the planning and tracking of activities, working with the assigned C&Q partner.
  
• Liase with the various stakeholders on the C&Q team and the overall project to ensure clear communication between all parties.
  
• Participation in GMP design reviews (DQ, CLIA etc), as required.
  
• Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
  
• Owner of pre-requisite C&Q Strategy and deliverables (System Level Impact Assessment, Component Level Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix).
  
• Oversees the generation, execution and approval of C&Q documentation in electronic format in KNEAT (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
  
• Review of CCRs and TOPs. May require travel to vendor shops and frequent communication with vendors to ensure documentation deliverables are per the VDRs.
  
• Generate C&Q change controls (FPIDCNs and PCNs) and drive their closure in a timely manner. Ensure non-conformances & deviations are minimised and closed out in a timely fashion.
  
• Responsibility for direct supervision of C&Q partner / suite team resources who are:
  
• Managing vendor engineers and contractors during C&Q activities.
  
• Managing the site attendance for the vendors, contractors and specialist contractors.
  
• Confirming all vendor documentation executions are compliant with GxP practices & the executed documentation is acceptable to support C&Q.
  
• Performing system P&ID walkdown with construction prior to handover. Categorisation of punchlist items & tracking to completion.
  
• Supporting review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise.
  
• Confirming the site installation is as per approved design specification and meeting system IQ requirements.
  
• Facilitating/expediting Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).
  
• Generating method statements, risk assessments & permit preparation for responsible areas from M/C to handover to site operations.
  
• Performing pre-start up safety checks, LOTO & ensuring timely loop checking and calibrations.
  
• Coordinating and supervising third party vendors during SAT execution. Reviewing and approving SAT protocols.
  
• Attending daily communication meetings with suite team lead and reporting progress.
  
• Assisting in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
  
• Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations.
  
• Implement C&Q strategies as aligned with the Global C&Q Lead.
  
• Ensure that system delivery progresses in accordance with the approved project schedule.
  
• Notify project management, in a timely manner, of all relevant issues which may impact on system progress.
  
• Ability to work in design and construction project environment within Ireland.
  
• Coordinate with design and/or project teams to resolve any identified technical issues.
  
• Organise/attend all coordination meetings necessary to progress the job. Possess good communication skills.
  
• Ensure that all works carried out in C&Q scope or responsibility by construction, commissioning and contract team members are performed in accordance with site safe working practices.
  
• Ensure the cohesive operation of cross-functional team and coordinate work for effective and efficient completion.
  

Requirements

Experience, Knowledge and Skills:

Working knowledge of process control systems and automation. DeltaV experience beneficial.

Advanced knowledge of C&Q documentation required for cGMP process equipment and utilities.

Experience using digital execution methods (ie. KNEAT) for digital execution of C&Q deliverables.

Fluent in English, written and verbal.

Ability to understand project plans and schedules.

Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.

Skilled in the strategy development, initiation, selection, coordination and management of projects and have ability to solve unique problems.

Knowledge of regulations and standards affecting devices, biologics and pharma products.

Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM.

Strong interpersonal and communication skills (verbal/written).

Qualifications/Requirements:

Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.

Minimum of 8 years experience in commissioning and/or validation of Drug Product/Facilities/Utilities systems within Pharmaceutical industry.

Technical knowledge of utilities, filling and formulation equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.

Minimum 5 years of experience with supervisory, project management and budget management are required.